Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00836043
First received: February 2, 2009
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.


Condition Intervention
Chronic Lymphocytic Leukemia
Drug: Alemtuzumab (MabCampath)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables. [ Time Frame: After first cycle of treatment, e.g. 12 weeks, then after 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Alemtuzumab (MabCampath)
Intravenous therapy according to product information.
Other Name: BAY86-5045

Detailed Description:

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)

Criteria

Inclusion Criteria:

In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.

Exclusion Criteria:

In accordance with Summaries of Product Characteristics (SPC).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836043

Locations
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Israel
Many Locations, Israel
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00836043     History of Changes
Other Study ID Numbers: 13418, 13858, 14241, MC0701, STAR
Study First Received: February 2, 2009
Last Updated: December 2, 2013
Health Authority: Bosnia: Federal Ministry of Health
Jordan: Ethical Committee
Romania: State Institute for Drug Control
Serbia: Ethics Committee
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Croatia: Ministry of Science, Education and Sports
Ukraine: Ministry of Health
Macedonia: Ministry of Health
Morocco: Ministry of Public Health
Turkey: Ethics Committee
Turkey: Ministry of Health
Israel: Ethics Commission

Keywords provided by Sanofi:
CLL
alemtuzumab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014